On Dessa and the Novartis Brand of Biomedical Engineering: Part 3

Examining the intersections of music, politics, the personal, and monopolized healthcare.

A note to subscribers: You can read the first posting here, the second posting here, the third posting here, the fourth posting here, and the fifth posting here.

The following is the third post of a serialization of an essay concerning monopolized cancer therapy and the hip-hop artist, Dessa - among other things.

If you haven’t already, you can read the first posting here and the second posting here. (I recommend reading them sequentially, since that’s what makes the most sense, but who am I to tell you what to do?) Enjoy!

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Previously, from last week’s episode:

“I started by asking about [Patrick’s] trip to China. He had been there to scope out whether or not certain hospitals could effectively institute the various protocols that are required in order to ensure that Novartis’ leukemia therapy, known as Kymriah, could be properly administered. Patrick later told me that Novartis is currently conducting clinical trials of Kymriah in China, with the intent of future commercialization of the drug in the country. As a reminder, Novartis owns the patent to this particular cancer therapy, but it’s not the only drug of its kind currently on the market. There are also more clinical trials of these kind of cell therapies in the works by other companies.

The way the drug works, very basically, is it involves taking blood from the patient, reengineering the immune cells found in the blood – specifically white blood T-cells – to begin destroying specific cancerous cells, and then reintroducing those modified T-cells into the patient. The patient’s blood needs to be harvested and handled in just the right way in order to make sure that it arrives at the Novartis labs in good condition and is re-administered to the patient correctly. Novartis currently has five locations where blood samples can be sent for the manufacture of Kymriah – in Switzerland, France, Germany, Japan, and its main lab in New Jersey. Novartis is also planning to expand its manufacturing capabilities into Australia and China.

Patient trials for Kymriah are currently being conducted in Shanghai. As Patrick later told me, since a patient’s blood needs to be sent to one of Novartis’ manufacturing sites, and since there is not currently a manufacturing site in China, they had to get special permission from the Chinese government to ship blood samples out of the country because China’s laws currently forbid the export of Chinese genetic material. Patrick said that this was the first time China had ever allowed exporting of genetic material, in this case to Novartis’ main lab all the way over in New Jersey. Eventually Novartis plans to open a new manufacturing site in Shanghai so as to avoid such long shipping times.

According to the FDA approval of Kymriah, the modified T-cells need to meet a certain minimum threshold of viable cell numbers in order to be considered within specification. Much of Patrick’s job is to travel the world making sure that hospitals which want to administer this treatment are following the proper protocols so that the treatment will be effective and within the appropriate specifications. There are currently about 260 qualified treatment centers for Kymriah around the world. Good job, Patrick!

In addition to these nuts and bolts questions, I wanted to know who could realistically get access to this cancer treatment, which is priced at $475,000 here in the US. Do health insurance companies even cover this expensive treatment? Patrick told me that a certain Saudi national had travelled abroad and was able to purchase the Kymriah therapy outright in cash. Thank god for all that oil money. Fuck those innocent Yemeni wedding parties, am I right?

I wanted to ask Patrick about Novartis’ ethos regarding this cancer treatment. Does the company take into account the ethical implications of determining a pricing model? How much does Novartis mark up the price in order to make a profit? However, I did not have the necessary underlying knowledge to be as probative as I wanted to be. We talked in a tangential way about the price of Kymriah and how the cost differs in different countries based on their respective healthcare systems. But I think what I really wanted to ask him then, and which I did not have the language to do, was why did this company Novartis have an ownership over this cancer treatment? This seemed like an awful lot of power bestowed upon an unassailable corporation.

But I did not yet know how to get to the heart of the issue because I did not understand the history behind this cancer therapy. I did not know about the relationships that Novartis and other pharmaceutical companies have, not only with our branches of government, but just as crucially with our university research departments.

If we’re going to have any chance of righting the fucked up healthcare system in this country, and indeed in the world, then it is essential to understand these private-public relationships. Let me try to explain.”

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                                                                    IV

                                            and I sleep, both eyes open
                                            standing up                    

                                       – Dessa, “Warsaw”¹

Novartis’ cell therapy, Kymriah, and others like it such as Gilead’s Yescarta, which is itself primarily used to treat lymphoma, are all a type of treatment called CAR-T therapy. CAR refers to “chimeric antigen receptor.” Basically, in order to get the patient’s T-cells to recognize and attack cancerous B-cells, the T-cells are infected with a virus which introduces a new gene into them. This new gene causes the T-cells to express the chimeric antigen receptor on their surface. The chimeric antigen receptor is what recognizes the specific antigens found on the B-cells, thus allowing the T-cells to target and destroy them.² It’s kind of like equipping your body with night vision goggles, thus giving you the ability to detect and annihilate the previously invisible threats all around you. How’s that for a metaphor? Whatever, fuck it, I don’t know, biology be crazy these days.

But this is important to understand because every pharmaceutical company that holds a patent for a CAR-T therapy is basically doing exactly the same shit. The only big differences between them is what kind of B-cell cancer they make the T-cells target and what viral vector they use to modify the T-cells. Novartis’ Kymriah is approved to treat leukemia and lymphoma, while Gilead’s Yescarta is only approved for lymphoma.³ They’re all just different brands of the same automobile. Each one gets you from point A to point B but maybe one gets a little better gas mileage than the others. Patrick used this same automobile metaphor when he was explaining it to me. “Yeah, well mine’s turbocharged,” he said. This is admittedly a bit too on the nose since these treatments are called “CAR”-T therapies.

If you want to get more technical, as Patrick was happy to do, these different cell therapies also act differently in how they get the T-cells to properly activate once they latch onto the cancerous B-cells. The first generation of these cell therapies only placed a CAR on the outside of the T-cells, but they didn’t mess with the rest of the internal genetics of the cells. But this didn’t work that great. The modified T-cells weren’t as consistent in attacking the B-cells as would be desired. These first generation CARs could identify the B-cells but they wouldn’t always activate the T-cell in order to destroy the cancer. So now, the 2nd generation treatments also modify the internal processes of the T-cells. These newer genetic modifications, called costimulatory domains, make sure that the T-cells are activated and remain so consistently enough to rid the body of the cancer. Novartis’ Kymriah uses a costimulatory domain called 4-1BB. Gilead’s Yescarta uses one called CD20. Got it? Good, because I don’t want to have to take a fucking oncology class in order to explain all of this.⁴

The genetic differences between Kymriah and Yescarta lead to differences in how they behave in the patient’s body. Yescarta works more quickly than Kymriah, wherein the modified T-cells destroy the B-cells at a faster rate. Yescarta’s modified T-cells are also flushed from the blood stream earlier and replenished by the body’s natural T-cells. This is good because so long as the modified T-cells are in a patient’s system, they are destroying all the B-cells. This is manageable, your body doesn’t need B-cells, but they do have a memory function for immune response. However, because Yescarta works faster, it also means that it intensifies CAR-T’s primary side-effects, neurotoxicity and cytokine release syndrome.

Also called a cytokine storm, this complication is rare but potentially deadly. “I’ve talked to some physicians,” Patrick told me, “and they’ve said, the first couple times that [cytokine release syndrome] happens, it’s terrifying, absolutely terrifying, because it seems like this patient is dying. But once you’ve figured out how to manage them through the crisis . . . it becomes not a big deal.” Cytokine release syndrome happens because B-cells are lysing (dying) at an extreme rate and releasing cytokines into the system, causing the patient to develop a fever, flu-like symptoms, and inflammation. Training hospitals in risk management and requiring them to have certain drugs on hand to deal with these side-effects are essential protocols that Novartis must adhere to as they onboard new care facilities for Kymriah.⁵

Currently, the French company Cellectis is developing CAR-T therapies which attempt to limit those adverse side effects by having kill-switches built into the modified T-cells, thus stopping them from attacking normal B-cells.⁶ Without built-in kill-switches, Patrick explained to me, you’re just waiting for the modified T-cells to eventually clear from the system. “But we have some patients where . . . we can’t identify any genetically modified T-cells in their system anymore. And some of those patients have no cancer, so, nobody likes to use the ‘cure’ word, but…”⁷ Go ahead, Patrick, use the “cure” word, it makes for a better story.

But even with these variabilities in different treatments, for our concerns, all of this minutiae is just the bioengineering equivalent of splitting hairs. All these different companies are using the same basic CAR-T therapy technique and manufacturing process. Patrick even told me: “The manufacturing process we use has had improvements to it but it is fundamentally the manufacturing process that Penn was using in their tiny little lab.”⁸ The University of Pennsylvania is where the first breakthrough clinical trials of CAR-T therapy were conducted. But more on that later.

I wanted to learn from Patrick what some of the current obstacles are to getting Kymriah and other CAR-T therapies more broadly available to the public. He laid out a few key issues: the rigorous requirements for getting hospitals on-boarded as treatment centers, the very labor intensive manufacturing process for the drug, and the difficulties in ensuring these types of cell therapies are profitable. Let’s first look at the process for getting cell therapies into hospitals.

When a hospital approaches Novartis, or Novartis’ marketing team approaches a hospital, in order to get Kymriah set up at their institution, there are many hoops which care providers have to go through in order to make sure the hospital can actually carry out the treatment. Kymriah requires the patient’s blood to be collected through a process called apheresis, which is similar to dialysis. Apheresis extracts the patient’s blood, separates the necessary T-cells, and then reinjects the blood into the patient. This process requires an apheresis machine that some hospitals may not already have.

Once the T-cells are separated, they must then undergo cryopreservation, being frozen down to liquid nitrogen temperatures. This process requires a cell lab, which most smaller hospitals probably do not have. But there are third party companies that offer cryopreservation for these cell therapies. In contrast, Gilead’s Yescarta therapy does not require cryopreservation, the cells remain fresh. But this then means that the turnaround time for getting Yescarta back into the patient has to be very quick. Kymriah’s freezing process allows for some more breathing room while the blood is transported to Novartis’ manufacturing sites and then shipped back to the patient at the treatment center.

Once the therapy has been manufactured at Novartis’ labs using the patient’s T-cells, it must then be reinfused and the patient must be monitored for side effects. As Patrick points out, neurotoxicity and cytokine release syndrome “are not side effects that are things that your general community hospital is used to dealing with.”⁹ And the drugs that must be on hand for helping to deal with these side effects may not be part of the usual stock of smaller hospitals. The FDA approval of Kymriah does allow for out-patient care, so long as the patient is within one hour travel time from the hospital. This proximity requirement would certainly present a challenge for rural communities where the closest registered care facility may be inaccessible from a patient’s home. Yescarta on the other hand requires in-patient treatment.

Given the barriers of these kinds of cell therapies to smaller community hospitals, the alternative would be to have those hospitals refer their patients to larger oncology centers that are already registered to use these cell therapies. But that presents another problem, namely financial competition. As Patrick explained to me:

Community hospitals are not always thrilled about referring their patients to big oncology centers because they often don’t get their patients back. The oncology centers take the referral and they hold onto the patients. And in our, let’s say, capitalistic world, the hospitals are making money off of their patients. And so when they lose patients to other hospitals, that’s a revenue steam that they’re losing. And so, probably not the most altruistic thing for them to hold onto patients that might be able to get a good product or therapy, but it does happen.¹⁰

Because of the for-profit healthcare system that we have in this country, rural community hospitals simply do not have the support that they need. As an article in the Democratic Left magazine points out, “More than 120 rural hospitals have gone out of business nationwide since 2005, and the trend is accelerating. Large swaths of the Mid-west lack rural hospitals, especially in those states that declined to expand Medicaid.”¹¹ Not only are low profits leading many hospitals to close down, it is also causing the ones which remain standing to avoid sending their patients to other hospitals where they may receive better treatment because they cannot afford to lose too many patients. This kind of privatized healthcare system is simply unsustainable and immoral.

And these issues with privatization are not endemic to healthcare. Efforts to privatize public goods and utilities, such as transportation, mail service, banking, and food distribution, lead to less profitable rural areas being priced out of reach or eliminated all-together. Treating public services as businesses inevitably causes harm to the people who rely on those services. If you’re not a profitable customer then fuck you, you’re not worth the time. This is how the for-profit healthcare system treats its patients.

Another issue that hospitals face when using these CAR-T therapies are the inspections and audits they must undergo by the pharmaceutical company. Novartis, Gilead, and other companies that have these cell therapies are currently required by the FDA to ensure that the “inputs” into their system for manufacturing these therapies, namely the patient’s own T-cells, are harvested safely and correctly. And so these companies are closely monitoring the hospitals to make sure that they are doing everything right. However, as Patrick explained to me, this a rather unusual way of doing business.

Normally, with traditional chemical drugs, such as ibuprofen, pharmaceutical companies get the raw material for their drugs from a supplier, and then the company manufactures their drugs with those raw materials. The pharmaceutical company is responsible for ensuring that their suppliers are all above board by doing inspections. But now, with these new CAR-T therapies, the only supplying that is done for the treatment is the hospital giving the patient’s T-cells over for manufacture. Under FDA rules, any treatment center that is involved with processing human tissue, such as T-cells, needs to be registered with the FDA as a tissue establishment. This would mean that the FDA would be the organization responsible for monitoring the hospitals that are dealing with tissue processing. When it came time to figure out how these new CAR-T therapies would be managed, it seemed that the FDA would be the most appropriate entity to monitor these therapies through their tissue establishment guidelines. But that’s not what happened.

Novartis specifically asked the FDA if these hospitals need to register with the FDA or update their current tissue establishment licenses since they’ll be doing white blood cell collections. “And the FDA explicitly said, no,” Patrick told me, “[The hospitals] should not register with the FDA. They should not update their registration. This is an input to [Novartis’] manufacturing process. You are responsible to ensure that inputs to your manufacturing are appropriate, not the FDA.”

And so now, every pharmaceutical company that has CAR-T therapies on the market is responsible for auditing and inspecting the hospitals for the work that they’re doing in providing the starting cells. The companies are treating the hospitals the same way that they would treat a supplier for traditional chemical drugs. But hospitals and drug companies are not used to this kind of arrangement. As Patrick explained, “The hospital is providing these cells, it’s a critical starting material for manufacturing, but a hospital is not a supplier in the sense of what is typically a supplier. They’re not in the business of supplying anything to anybody. They’re a healthcare provider and that’s their business.” These audits by the pharmaceutical companies present several problems.

Firstly, as mentioned above, hospitals are not used to being treated like a supplier in the drug manufacturing chain. They do not have the staff and the resources to deal with all the audits from pharmaceutical companies. Secondly, every company has different requirements for their cell therapies, some of which are ridiculously exacting. Patrick told me that different companies even have different standards for exactly how long the tubes on the blood bags that hold the patient’s plasma need to be. “Some say we want a 12 inch tube, some are saying we want a 6 inch tube, some are saying we want an 8 inch tube that has two crimps in it, some say we want 3 crimps.” This level of detail and variability takes a toll on hospitals that only have so much bandwidth.

And as more cell therapies are developed, each with its own set of requirements and inspections from the company, at some point a hospital will not be able to take on any new treatments simply because they do not have the time and the staff to manage all the variability. This isn’t just a barrier to getting already approved cell therapies into hospitals. Pharmaceutical companies also often rely on hospitals to conduct clinical trials for new drugs that are in development. If a hospital is already overburdened by too many cell therapies then they are less likely to take on a new clinical trial as well. “And that’s not good,” Patrick said, “because that small company that comes along may have the next great thing. And maybe it’s having a hard time getting into trials because the hospitals are saturated by too much variability already.”

Because of this over-complication, the hospitals are asking the drug companies to get together and simplify their requirements. In addition to his job at Novartis, Patrick is part of a group that is working on standardizing CAR-T therapies across the industry, so that hospitals can stop worrying about the specific length of blood bag tubes, among other things.

Besides all of the issues with onboarding new hospitals, drug manufacturers have been having a difficult time with reliably manufacturing these cell therapies. Every dose of Novartis’ Kymriah is an individualized treatment that is time consuming to create and quite labor intensive. It usually takes around 21 days for the drug to be manufactured at Novartis’ labs, and the pressure is on, given how sick the patients are.¹² Kymriah currently has FDA approval as a third-line treatment, meaning that a patient must have gone through two prior rounds of traditional chemotherapy, and have either not responded to those treatments or relapsed both times, before Kymriah can be used for the third round of treatment. This often means that patients are on their last legs. “These patients have been on chemo and drugs for years so they’re extremely frail,” Patrick told me, “We’ve had patients die waiting for product manufacturing to complete.”

Novartis is currently trying to streamline its manufacturing process for Kymriah in order to speed up the turnaround time. In addition to this, Kymriah is currently in clinical trials, known as the “Belinda” trial, to try to get the drug approved for second-line treatment. Not only would this new approval get Novartis healthier patients to work with, it may also improve the efficacy of the drug itself. Currently, under Kymriah’s FDA approval requirements, 80% of the modified T-cells must be viable, living cells when infused into the patient. Part of Novartis’ manufacturing struggles have been not being able to consistently meet this 80% threshold.¹³ But if the drug were approved for second-line treatment, the patient’s T-cells would be healthier, not having gone through two successive rounds of damaging chemotherapy, and may therefore yield more viable cell numbers.

In an ideal world for Novartis, they would be able to use patient T-cells that are totally untouched by destructive chemotherapy. “We know that prior therapies can have a big impact on the robustness and how healthy the T-cells are,” Patrick told me. “I’ve said to people before, if I was diagnosed with [lymphoma] tomorrow, before I had any chemotherapy I would have myself apheresed and have my T-cells frozen.”¹⁴ One wonders if having your T-cells frozen would be an option for any old, run-of-the-mill patient, even if they were one of the few who would be aware of CAR-T treatments in the first place and could ask for such a service. Something tells me we’re going to be stuck with shitty, chemo zapped T-cells for a long time.

Another set of issues that pharmaceutical companies are dealing with is how to ensure that these CAR-T therapies are profitable. Patrick told me that Kymriah is not at the profitability level that would be desirable for Novartis (no amount of profit is ever enough, don’t you know?). The drug is intended to be a one-time, single dose – so the company cannot rely on ongoing treatment payments the way that traditional drugs would. And since these therapies are so new to the field and so individualized per patient, the cost of manufacturing them is still relatively high. Progressing towards a “platform” manufacturing model – using the same standardized techniques and equipment for all CAR-T therapies – is a long term goal for the industry. But the current customized and bespoke approach is a long way from such a platform manufacturing model.

In addition to costly manufacturing hurdles, the number of patients per year that would qualify for Kymriah are relatively low. Leukemia and lymphoma are less common cancers and most people do respond to chemotherapy treatments. But the hope is that CAR-T therapies will eventually be used to treat all patients with these type of cancers, regardless of their response to chemo, thus greatly expanding the market.  

Novartis has been experimenting with different payment models for Kymriah. They currently have what is called outcomes-based pricing for pediatric use of the drug. This means that if the treatment is ineffective for those below a certain age, then Novartis does not invoice for it. It is unclear how many free treatments Novartis has had to give out, and therefore unknown how much this has cut into their profits. But the company was hoping that Kymriah would eventually be a “blockbuster” drug, making upwards of $1 billion a year in sales. They have yet to reach that lofty goal since Kymriah first got FDA approval back in 2017.¹⁵

Despite all of these growing pains, the curative promise of these therapies has led to an enormous proliferation of research and development in the cell therapy field. Patrick told me there are currently hundreds of ongoing clinical trials in the CAR-T space. Even if it may be challenging for large companies to find a sustainable pricing model for these kind of therapies, they would much rather figure it out for themselves than have a smaller, more nimble startup firm develop their own curative CAR-T therapy and thereby put the big pharma oncology divisions out of business. But the likelihood of the small guys beating the big guys is slim. “I think those little companies will have a hard time,” Patrick said, “If big pharma is fully in and fully invested, the amount of resource that a company like Novartis can throw at a product is enormous.”¹⁶

Smaller companies with less funding are also at a disadvantage because of all of the patents involved in the cell therapy space, let alone the pharmaceutical industry in general. Licensing and legal fees for using patent-protected material can be enormous. And even if a patent allows free use for research and development purposes, if a small company gets to the point of having a CAR-T therapy ready for commercialization, those patents will then kick in to take a cut of the sales.

The economist Dean Baker notes that the costs associated with these patents, “can make the research to develop new drugs and medical diagnostic products considerably more expensive and thereby slow the process.”¹⁷ The current patent system favors large, established firms over the little guys. So who owns some of these patents in the CAR-T space? This brings us to the question of how this cancer therapy was developed in the first place.

The origins of CAR-T treatment began in the 1980’s when scientists supposed that they could engineer T-cells to attack other cells displaying specific antigens, such as cancer cells.¹⁸ This work was spearheaded by both public institutions and private universities receiving public funding, such as the University of Pennsylvania. Dr. Carl June, a professor at the University of Pennsylvania, is considered one of the vanguard in the research and development of CAR-T therapy. It was at the University of Pennsylvania’s medical school where Dr. June directed the first patient trials of a CAR-T therapy in 2010, at the time referred to as CART19. After a 6-year old girl was successfully treated for leukemia in 2011, Novartis took notice and swooped in to partner with Dr. June and Penn in order to provide further funding for research and development and to secure the rights to commercialization of the therapy.¹⁹

Patrick was hired by Novartis shortly before this partnership with Penn took place. “We pretty rapidly did a tech transfer from the very, very small manufacturing facility at Penn,” Patrick told me, “I think that facility had five little rooms where they were doing [CART19]. . . . So they really did not have the capacity to scale up.” And Patrick explained that Penn was pretty savvy when it came to negotiating the partnership with Novartis. “Penn wasn’t looking for somebody to just commercialize the one product. They were looking for, essentially, a research partner to work with. . . . Penn said very upfront, ‘If all you want is to license this in, then we don’t want to do business with you . . . we want a full collaboration.’” And that’s what Penn got. The full collaboration with Novartis lasted for seven years.²⁰

So the research and development for these therapies was ultimately funded by both the public and the private sectors. Depending on who you talk to, who paid how much for what varies considerably. Neither Novartis nor the University of Pennsylvania responded to my questions asking for an accounting of the funding numbers. This kind of stonewalling is par for the course for Novartis. When asked about the manufacturing costs for these cell therapies, a Novartis representative said that the numbers have "never been made public and cannot be for proprietary reasons."²¹

According to prior statements made by Novartis’ former CEO Joseph Jimenez from 2017, they estimate that they spent more than $1 billion on bringing Kymriah to market. In comparison, according to the consumer advocacy organization called Patients for Affordable Drugs, the government-funded National Institutes of Health (NIH) spent approximately $200 million on CAR-T research at the University of Pennsylvania.²² By Novartis’ own recent forecasts, Kymriah is set to make upwards of $1 billion a year in sales (hopefully, as the CEO makes a blood sacrifice and prays to the American God of Corporations).²³ Add on top of that the approximately $1.2 billion that the company has already made selling Kymriah, and Novartis will has already made back their research and development costs and then some.²⁴

Regardless of who ultimately paid how much for what, the initial research, development, and patient trials of CAR-T cell therapy were conducted by professors and researchers at Penn before Novartis ever came into the picture. And in the FDA approval documents that were submitted by Novartis to get Kymriah ready for the market, Novartis used the critical safety data that came from the original patient trials conducted by Penn.²⁵ Novartis now owns the patent for Kymriah and continues to develop other CAR-T therapies and patent those as well. The University of Pennsylvania has said that some researchers involved in the invention of certain technologies used in CAR-T therapy currently own patents on those technologies. This allows those researchers and the university to have continued revenue from the use of those technologies.²⁶

Universities are able to patent their technologies because of a 1980 law called the Bayh-Dole Act.  This law, as explained by economist Dean Baker, allows for “universities, research institutions, private companies, and individuals operating on government contracts to gain control of patents derived from their work, thereby creating the opportunity for universities to earn large rents from patents and for researchers to form their own companies, all relying on knowledge and expertise obtained on government contracts.”²⁷

The Bayh-Dole Act, signed into law by president Jimmy Carter, came after decades of the corporate class attempting to whittle away at the protections in place to keep public research in the hands of the public. Prior to Bayh-Dole, any patents that arose from government research would be held by the government, freely available for anyone in the public to look up and build on the research. Greedy companies, seeing that they could increase their profits by securing more exclusive patents based on public research, engaged in dishonest PR campaigns, disseminating misleading talking points that US companies needed to maintain “global competitiveness” by securing more patents. In reality, giving more patents over to private corporations slowed down innovation, while at the same time it wrested power away from the public, smaller businesses and research firms, and consolidated that power in a smaller number of hands.

In 1979, during a Senate subcommittee convened to discuss the proposed bill, Navy Adm. Hyman G. Rickover stated bluntly in opposition:

Government contractors should not be given title to inventions developed at government expense. These inventions are paid for by the public and therefore should be available for any citizen to use or not as he sees fit.

And this same debate about the proper placement of patent rights had already happened during the post-WWII years, when government funded research was exploding in the US. In 1946, during a senate hearing discussing the issue, Horace M. Gray, an associate dean of the graduate school at the University of Illinois, put it even more pointedly than Adm. Rickover did in 1979, saying:

[It is] quite unthinkable that the Federal Government should tax the citizens of this country to secure funds for scientific research, on the grounds that such research promotes the general good, and then turn the results of such research over to some private corporation on an exclusive, monopoly basis. This amounts to public taxation for private privilege and violates one of the basic tenets of our democratic faith. [emphasis added]²⁸

The Bayh-Dole law has been a revolution for corporations seeking to maximize their profits at the public’s expense. But, on the one hand, the law does allow for universities to receive royalty payments every time a commercial drug that they helped developed gets sold. This could also help support small private research teams – which often branch out from universities and which don’t necessarily have lofty commercial interests – to continue development on therapies that bigger companies may not be interested in working on, at least not until those big companies can swoop in and buy out the little guys after all the hard work has been done. But on the other hand, this law allows for private corporations to commercialize therapies which were largely researched using public dollars. Research takes time and is risky so why not let the taxpayer take on that risk? Once a drug seems commercially viable then the big adult capitalists can step in to soak up the profits made from selling the drug back to the people who originally funded it.

This taxpayer funded research, mostly supported by the NIH in the case of healthcare research, is essential for laying the groundwork for further medical breakthroughs. As one study pointed out, NIH funding “was associated directly or indirectly with every drug approved from 2010–2016.” Not just some drugs, every drug. This same study also noted that any decrease in NIH funding would not likely be made up for by corporations due to “the limited incentives for companies to make investments toward basic research that would negatively impact near-term earnings, offer uncertain competitive advantage, and may not generate profitable products for decades.”²⁹

Another study found that global competition was associated with firms shifting priorities away from basic research and towards “commercial application and protection of existing knowledge.” Just like how corporations spent their time lobbying for the passage of the Bayh-Dole Act. That study’s authors also noted that “Unless public funding can make up the deficit,” which it won’t, unless there is a huge shift in the way taxpayer dollars are spent in this country, then “technical progress will slacken and eventually reduce productivity growth.”³⁰

Isn’t that great? Pharmaceutical companies are shifting money away from research and towards more patent protection, thus slowing progress for new therapies. We’re not in the business of researching life-saving drugs for the good of humanity! We’re in the business of business! It’s a big, scary, competitive, globalist world out there and we’ve got to make a profit on these drugs, human sacrifice be damned! Can someone justify to me again why private companies are in control of our healthcare?

Ultimately, we are left with the fact that Novartis and other for-profit pharmaceutical companies own the patents for the administration of these therapies to patients; therapies which cost hundreds of thousands of dollars due to their monopolization and are therefore difficult to gain access to, as in the case of Gilead’s $373,000 Yescarta, which was initially considered too prohibitively expensive for use with the U.K.’s National Health Service.³¹

There are no generic forms of CAR-T therapies and therefore little competition in pricing. Novartis currently has a functional monopoly on CAR-T treatments for leukemia. And these pharmaceutical companies are not ultimately beholden to public health concerns. They are beholden to their stock prices and the continued happiness, or rather smugness, of their shareholders.

Patients for Affordable Drugs made the claim that Novartis could price Kymriah at $160,000 instead of the current $475,000 price in the U.S. and still make a profit.³² Novartis would of course dispute this claim. Patrick said that the company spends a lot of money to manufacture Kymriah and that there are ongoing costs from the drug’s research and development. But the price for Kymriah in the U.K. is comparatively low at $361,000.³³ This probably has something to do with, at least in part, the NHS’s ability to collectively negotiate drug prices in the U.K., something that the US pharmaceutical and health insurance industries will not allow to happen in the US. But if Novartis wants to make the claim that the price of their drugs reflects the initial development costs and continued research and manufacture costs, then how can the company justify such large discrepancies in the prices between countries? Is it maybe just because Novartis and other drug companies price their treatments as high as they think they can get away with in order to maximize the profits earned from ransoming a life-saving cancer therapy?

Now, to be fair, there have been cases where Novartis has administered CAR-T therapies at little to no cost to the patient, in addition to the aforementioned outcomes-based pricing for pediatric use. But don’t start applauding just yet. Remember how the FDA mandates that Kymriah have a certain number of viable T-cells? The current FDA standard is that 80% of the modified T-cells must be alive when administered into the patient. In the few cases where Kymriah was given away for free, it was because the treatment had been manufactured below these specifications and thus Novartis would not be allowed to charge for the treatment under current FDA rules. Novartis is now trying to get the FDA to lower the viable cell threshold level down to around 70%, probably because they don’t want to keep being forced to give away free treatments to dying people.³⁴

Despite the low “profitability level” of Kymriah, Novartis is going all in on investing in the treatment. As Patrick told me: “It’s a unique product in the field, it’s a first in the field, it’s a potentially curative therapy, so I think Novartis is giving it a bit of wiggle room.”³⁵ The curative promise of CAR-T treatments will lead to a proliferation of drug development in the field as well as ever more patenting of as many products as possible involved in the cell therapy space.

And what do these patent protections give us? Mostly an increase in prices and a reduction in free and open research. And none of us has a say in any of this. When universities decide to license their medical breakthroughs to corporations, it’s basically a private deal without much public input. The NIH is technically responsible for approving commercialization of drugs developed by universities that received NIH funding. But this is basically a rubberstamping process – more on that later.

It’s all well and good for university research departments to earn money off the patents they own. They can use those dollars to pay for their bloated administrative staff and to give their president another bonus! But even if the universities are using their patent rents to fund further research and development, where is the democracy in that decision making? We’re not talking about a university patenting a new and improved fidget spinner. We’re talking about universities selling off the rights to cutting edge, life-saving drugs that have tremendous import for all of humanity. And the control of these therapies are being given over to the worst institutions imaginable: giant pharmaceutical companies. These corporations are the best in the world at monopolizing their treatments and setting drug prices at the perfect number to get just enough people to buy from them to net them a profit, while the rest will suffer and die because they can’t afford the treatment. And where does all that money go? It goes less and less to research and more and more to advertising, political lobbying, and securing patents.

These pharmaceutical companies will constantly rationalize their monopolized drug prices as necessary in order to fund continued research. Patrick even told me that Novartis relies upon the profits generated from patent protected drugs to fund products that are in the development phase and even the products that are early in their commercial life cycle. We are expected to put up with ludicrous patent-protected prices because that is what supposedly funds further research and development. This argument is nicely summed up by Alan Sager, a professor of public health at Boston University:

The promise of innovation persuades many Americans that high drug prices are warranted. An emotional and intemperate metaphoric formulation of the drug makers’ implicit position might be ‘give us all your money or you’ll die.’³⁶

While Mr. Sager may call this formulation “emotional and intemperate,” I would call it wholly justified. Some of us have no healthcare insurance and make less than $30,000 a year, so I think a bit of emotionality and intemperance are long overdue, thank you very much.

But the problem with this argument put forth by patent apologists is that, in addition to the aforementioned fact that companies are spending less money on basic research and instead leaving that work to the woefully underfunded NIH, these companies aren’t even spending most of their profits on any kind of research.

In their book Against Intellectual Monopoly, Michele Boldrin and David K. Levine point out that Novartis spends approximately 33% of its sales on promotion, while only spending 19% on R&D. They found that these numbers were similar industry-wide, showing that “the top 30 firms spend about twice as much in promotion and advertising as they do in R&D.”³⁷ They also point to the work of Alan Sager, who found that the number of R&D employees in the pharmaceutical field declined between 1995 and 2000, “while the number of people working in marketing shot up 59 percent.”³⁸ Shouldn’t we be spending more money on researching new types of therapies instead of throwing resources at relentlessly marketing the old ones to baby boomers watching CNN? The current patent system does not incentivize such action.

Here is a rundown, by no means comprehensive, of the many issues with our current patent laws. The first and most basic thing to note is that patents increase prices. They do this so consistently and blatantly that it would be fair to say that the primary purpose of patent protection is to raise prices for consumers. As Dean Baker explains: “These protections can often raise the price of protected items by several multiples of the free market price, making them comparable to tariffs of several hundred or even several thousand percent.”³⁹ Baker points to the example of a hepatitis C drug sold in the U.S. for $84,000 for a three month round of treatment, while generic versions are available in India for as low as $300.⁴⁰ Patent protection consistently stifles any competition from entering the market, thereby ensuring monopoly prices.

In addition to increasing the price of drugs themselves, patents also increase the price of research and development. In an area like biotechnology, the equipment, tests, and biological materials are subject to patents requiring payments for their use. These costs prevent smaller developers from being able to bring new drugs to market and it makes it more difficult for them to be profitable.⁴¹ And the publication of the patents themselves – a system where new technologies are written up and disseminated publicly and which is supposed to let other people learn about new products –  is actually not great at sharing this knowledge because firms often deliberately write up their patents in opaque, unintelligible language so as to keep competitors from learning how the protected material works.⁴²

These factors stifle the development of new products by preventing researchers from being able to work in a free and open-source community of ideas. Why are healthcare and pharmaceutical companies keeping secrets from each other and fighting over access to patients when, ostensibly, their goal is to improve the collective health and wellbeing of people? It’s because their profit motives far outweigh every other concern.

Other countries besides the U.S. that have adopted patent laws have predictably suffered the same deleterious effects. After Italy adopted the use of patent protections for its pharmaceutical industry, development slowed considerably. Regarding this, Boldrin and Levin point out that, “neither the size, nor the innovative output, nor the economic performances of that industry have improved, to any measurable extent, during the thirty years since patents were adopted.”⁴³ And these effects have held true across decades. A 1961 study found that countries with no patent protections developed 10 times as many drug inventions as countries with patent protections, and had lower drug prices.⁴⁴

High patent-protected drug prices mean that most treatments are priced out of reach of the majority of people. This ensures the perpetuation of the for-profit health insurance industry, which approves or doesn’t approve payments for treatments on a whim, beyond the reaches of accountability to their customers. (We’ve all heard the horror stories of patients arguing with their insurance companies over the phone for months in a Kafkaesque system that is designed to discourage you and keep your bills from being properly covered.) But if patent protection was abolished or highly curtailed, and thus generic drugs were allowed to enter the market, then drug prices would go down, as would be expected in a truly competitive free market. As Dean Baker points out: “With drugs selling at prices that even middle-income families could readily afford, the whole industry of middle-men that has grown up around mediating between the drug companies and insurers, hospitals, and patients would disappear. There would be no need for it.”⁴⁵

Because of the incentive for companies to protect their patents in order to keep drug prices high, they will often collude to buy out smaller competitors or pay them to delay bringing a generic drug to market. A 2010 study by the Federal Trade Commission estimated that the annual cost to consumers for these pay-to-delay tactics was $3.5 billion.⁴⁶ These pay-to-delay behaviors are considered illegal under current law, but those laws are barely enforced.

Also, because patent-protected drug prices are so desirable for companies, this leads them to shift their research and development energies towards drugs that already have proven commercial value. If a current drug is making a lot of money, other companies would rather develop copycat drugs in order to get a share of the profits instead of developing new drugs for illnesses with unproven market potential.⁴⁷ This means that development of treatments for rare terminal illnesses, which by definition will be less profitable, slows to a crawl while resources spent on “me-too” drugs continues to grow. Boldrin and Levin summarize the effects of this behavior well: “Money spent in obtaining a ‘me-too’ drug that can be patented is money denied to society and charged to consumers”⁴⁸ We lose out on new treatments for rare forms of cancer while pharmaceutical companies are busy hawking their patent protected heart burn medications over the airwaves.

Instead of relying on for-profit pharmaceutical companies to develop and manufacture new drugs, we should expand NIH funding in order to focus on treatments for illnesses that would otherwise garner little attention from the private sector because of low profitability levels. Another reform that could be instituted, argues Alan Sager, would be to abolish patents altogether and instead award prizes in proportion to a new drugs’ societal value.⁴⁹

And the big argument that drug companies use to defend patents, that it allows them to fund continued research and development and conduct costly clinical trials, could be mitigated by using government funding for the clinical trial process. Boldrin and Levin note that since a pharmaceutical company will be the first to market its new drug after getting out of the clinical trial phase, they have a strong conflict of interest in regards to setting up their trials and publishing their results - they don’t want all that time and money to go to waste. But if the clinical trial process were publicly funded through “competitive and peer-reviewed NIH grants,” as suggested by Boldrin and Levin, then there would be no need to rely upon monopoly drug prices to fund new drug development and the pricey clinical trial process.⁵⁰

The way things are now, private companies receive public funding for drug development, but the public has no stake in the resulting medicines and no say in how they are administered. As we have seen with the development of Covid-19 vaccines, when governments and industries focus all their energies on developing a treatment, they can get things done much faster than they would if left to their own profit-seeking devices. But even though Covid-19 vaccines were developed at a record pace using public funds, pharmaceutical companies still have intellectual property rights on those vaccines, thereby limiting who else can produce them and where they are being administered.

Moderna received $1 billion from the U.S. government to develop its Covid-19 vaccine. The Pfizer-BioNTech vaccine received $445 million from the German government. And the Johnson & Johnson vaccine was spurred by over $1.45 billion in funding from the U.S. government. And who owns these vaccines? The companies do, not the people. Wealthy Western countries have been monopolizing access to the vaccines, to the point where countries such South Sudan, Mali, and Zimbabwe are predicted to not have significant portions of their populations vaccinated until as late as 2024.⁵¹

Poorer countries in the global South which have yet to receive Covid-19 vaccines have put forward a measure calling on the World Trade Organization to waive patent protections for these vaccines. This measure was supported by 99 countries but has been blocked by wealthier nations such as the U.S., EU members, Japan, the U.K., and Australia.⁵² Rich countries that are already vaccinating their populations are refusing to allow poorer countries to get their hands on the vaccines, thereby ensuring more death and the proliferation of Covid-19 variants.

The big pharmaceutical companies – again, which received government funding for these vaccines and are estimated to reap $21 billion in profits from their sales in just 2021 alone – are now pressuring the Biden administration to punish poorer countries that are looking to subvert vaccine patent protections and develop their own generics. These punishments could likely take the form of sanctions or trade tariffs. The U.S. government has done the bidding of pharmaceutical companies like this before. In 2006, when Thailand began issuing licenses for generic production of HIV medications and cancer therapies, the drug industry called on the U.S. government to punish Thailand, which resulted in tariffs being imposed on Thai exports.⁵³

So, if you are a poor country that wants to produce generic drugs to help treat life-threatening illnesses in your populace, then you are considered an enemy of big pharmaceutical corporations and therefore also of the U.S. government – which are basically one and the same – and you will suffer economic consequences. How is this not considered an act of war? How is it not an international crime for corporations to dictate how sovereign countries manage the healthcare for their own citizens? Corporations are ensuring continued death on a global scale in order to protect their profits.

Wealthy Western countries are totally aligned in protecting corporate interests at the expense of human lives. In their mind, people in underdeveloped countries are unworthy of equitable healthcare, they are lesser human beings deserving of death and depredation simply because they are poor. Better to protect patents than to stop a global pandemic.

Additionally, our for-profit healthcare system in the U.S. is an international abomination. One recent study estimated that one-third of U.S. Covid-19 related deaths would have been prevented if we had universal healthcare free at the point of service.⁵⁴ That’s approximately 176,000 people whose deaths could have been avoided if our country chose to value people over profits. With universal healthcare, more people would have received essential preventative care, rural hospitals could have been adequately funded, healthcare facilities could have been prepared with the proper equipment, and ordinary people would not have been afraid of incurring astronomical medical bills when seeking treatment.

The people in power are evil incarnate, plain and simple, and they are utterly shielded from the devastation they wreak upon the rest of us. It is far past time for the people to get what is owed to us, what we have been denied for so long – equitable treatment, truly democratic government, and the right to live healthy and prosperous lives free from corporate tyranny and exploitation.

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It’s perfectly reasonable to question the amount of corporate control that is currently exerted over the healthcare industry. And while it’s true that private companies offer up enormous amounts of capital and infrastructure to help with research and development of new treatments, who ultimately gets the better end of the deal? Corporations or patients? And do we really want to live in a world where our healthcare infrastructure relies so much on private interests to fuel innovation? Would it not be much more in the public’s interest for innovation in the healthcare system to be primarily funded by public dollars? Particularly when the technologies that result from this innovation are ostensibly for the express purpose of improving public health and well-being?

The U.S. government, through the NIH, already spends more than $41 billion a year on medical research.⁵⁵ Why don’t we just fund that more? How about we shift some of the money from the ridiculous $768 billion set aside for the military as stipulated by the most recent National Defense Authorization Act passed overwhelmingly by both sides of congress?⁵⁶

And what if we wanted to reform the current patent system? Well, big pharma simply will not allow that. As Zephyr Teachout points out in her book Break ‘Em Up, in 2019 pharmaceutical companies “spent a record $200 million on lobbying, working to make sure the government doesn’t start regulating prices, blocking their mergers, or reforming patent law.”⁵⁷ This behavior holds true even beyond U.S. borders. When India passed a law restricting drug companies from carrying out “evergreening,” the practice of making slight modifications to existing drugs in order to continuously extend their patent protections, Novartis sued the government and took the case all the way to the Indian Supreme Court in order to ensure it could charge its monopolistic price for its cancer therapy known as Glivec.

Thankfully, in 2013, the Indian Supreme Court decided against Novartis, refusing Glivec patent protection and thereby ensuring a generic market. As an article in Intellectual Property Watch points out, the price of Glivec in India dropped from $2,200 for one month of treatment down to just $88.⁵⁸ It’d be nice if the U.S. congress and court system had the same fortitude that India does. But drug companies have continued to try to chip away at the Indian law and will predictably support anti-consumer international trade treaties such as NAFTA. One small win for consumers with a case like this is just an exception to the corporate rules, and it requires constant vigilance and opposition to keep the forces of corporatism at bay.

What if somebody wanted to challenge the practice of universities giving over their developments of life-saving drugs to private ownership? Well, we have an example of just such a case. In 2018 the nonprofit organization Knowledge Ecology International (KEI) sued the NIH over exclusive licenses for CAR-T therapies that the government gave to the company Gilead. KEI claimed that the development for these CAR-T therapies were funded in part by public dollars and so the NIH’s decision to grant an exclusive patent to Gilead was both anticompetitive and against the interests of the public.

The NIH countered back and filed a motion to dismiss the case, claiming that KEI had no standing to bring the lawsuit. The court agreed. The judge wrote that KEI could not demonstrate that someone had suffered an “injury-in-fact” caused by the proposed patenting of the CAR-T therapy. This is what was said in the court opinion:

The only specific injury-in-fact alleged, however, is to one of KEI’s Board of Directors, James Love, Director of KEI, who refers to a family member who has been diagnosed with a cancer and who may possibly benefit from the therapy covered by the license in this case. And Love himself is cited as being affected by the high price of cancer drugs and treatments in general. Respectfully, these invocations stretch the concept too far. These purported injuries-in-fact, the Court believes, are too speculative and too removed from the association itself to confer standing.⁵⁹

So let me get this straight: if I want to sue the government in order to stop a shitty business deal between a government agency and a private pharmaceutical company, a deal where the government is trying to give away publicly funded medical treatments over to the exclusive ownership of a corporation, then I have to be able to prove that I have already suffered an “injury-in-fact” caused by this deal which hasn’t even happened yet? Are you kidding me? That’s like saying that I can’t sue my neighbor to stop him from turning his garage into a uranium enrichment plant because I haven’t yet been poisoned by the radiation that would definitely emanate from his garage into my house. This is madness.

But it just goes to show that, however well-meaning KEI is as an organization, the current courts are the worst way to go about securing any protections for the people against healthcare corporations. For starters, the judicial branch, by its very nature, is a conservative institution. Courts can only operate in so far as the current laws allow them to. Judges have the leeway to interpret legislation, but they cannot makeup laws out of whole cloth. And more particularly in this case, since the adoption of the Bayh-Dole Act, the government now has the burden to prove that its ownership of a patent better serves the public than a private monopoly, not the other way around.

And going up against the government or a well-funded corporation will always be an uphill battle. Justice department officials often go on to represent the corporations they had previously been watchdogs for, bringing with them valuable insider institutional knowledge, and vice-versa. If you want to try to sue the companies directly, then you better be prepared to go up against the best lawyers that money can buy. This suit brought against the NIH was doomed from the start.

But KEI was focusing on the wrong things. They shouldn’t have been trying to demonstrate “injuries-in-fact.” They should have been arguing for an antitrust case. But how can you get the government to enforce anti-trust law when the government itself is the one who is doing the trusting with corporations? As Zephyr Teachout points out, after Ronald Reagan’s conservative revolution, the Reagan appointed courts were loath to enforce antitrust law, turning back decades of what the laws had been intended to do in the first place. “They rejected a vision that these laws were designed to curb despotism,” Teachout writes.⁶⁰ And we are seeing the fruits of this lack of antitrust law enforcement. Our economy is more consolidated and controlled by fewer corporations than ever before while inequality skyrockets. Since the start of the pandemic, billionaires have increased their collective hordes of treasure by $2.1 trillion.⁶¹ Meanwhile, millions of people have lost their jobs and millions are dead around the globe.

Court cases taking on corporate hegemony may be valiant, but given the state of our courts, these efforts are also Sisyphean. As labor organizer Jane McAlevey points out:

In the United States, we are stuck with a high court that will rule against workers and the planet for another thirty to forty years. Lawsuits, legal approaches, and advocacy, the modus operandi of choice since the early 1970s for those who self-identify as progressives, simply will not work.⁶²

If you want to bring the insurance and pharmaceutical industry back under the regulatory umbrella of antitrust laws, end the for-profit healthcare system, and abolish privatization and corporate control of medicines, then forget about trying to take people to court. It’s not just that you’re unlikely to win. It’s that you’re spending energy and money fighting over the completely wrong things. We shouldn’t be trying to stop the government from giving away our publicly funded technologies. We should be making sure that the corporations that try to steal them from us don’t even exist in the first place.

Every branch of our government is captured and beholden to corporate interests. The close relationships that pharmaceutical companies have with the government just exposes one of the lies of our modern-day free-market ideology. The corporations want to be able to have their cake and fuck it too. They want to be able to privatize and make profits on commodities, but at the same time they want government protections against too much pesky competition, yet they also can’t stand, heaven forbid, reasonable government regulations on their business practices.

People like to defend our modern version of the “free-market economy” by saying that it spurs innovation and maintains healthy competition. But these companies are not competing on price and quality of care. They’re competing for the power of the state to award them exclusive patents, thus allowing them to dictate prices with no alternative.

The modern conservative and U.S. libertarian view, and indeed the dominant neoliberal ideology, unendingly place their faith in the so called free-market economy. The idea of the free-market is used to defend the current capitalist system in the U.S. as well as our globalized economy. However, our current economic system is effectively an inversion of the sort of labor equality utopia that classically liberal writers such as Adam Smith and Thomas Paine championed. Those thinkers’ version of a free-market economy at the time stood in opposition to the feudalism, oligarchy, and social hierarchies of lords, nobles, and kings.

The classical liberal version of the free-market envisioned the majority of the labor force working for themselves and not for wages. Skilled artisans with at most only a few employees would ply their trades and sell their goods and services on equal standing with everyone else within the market. But this does not in any way resemble our current system of small groups of ultra-wealthy capitalists hoarding wealth and power, controlling the systems of government and law, and monopolizing huge sections of the economy to the point where most workers have little opportunity to be self-employed or to sell their labor elsewhere for better conditions.

And yet free-market capitalists continue to defend our current economic system by using an outmoded ideology that does not remotely describe our modern day capitalist version of feudalism and oligarchy – which is what our current state of corporate lordship may be accurately described as. When obscene amounts of money buys access to power and policy creation and relegates everyone else to irrelevance, when corporations partner with the criminal justice system and military apparatus in order to protect their own interests by criminalizing civil disobedience and direct action, and when the courts consistently favor companies at the expense of individuals and labor movements, then it cannot be said that we live in a democracy.

Adam Smith and Thomas Paine would be appalled at the lack of freedom enjoyed by the modern American worker and how little socioeconomic standing and power they have in relation to the elites in the society. And the sorts of social safety net programs that the libertarian Paine argued for by way of interpreting Locke’s philosophy on natural rights, such as disability payments, survivor benefits, and old-age pensions, are constantly attacked by those claiming to defend free-market ideology.⁶³

People cannot participate in a supposed free-market economy when they’re too sick or too old or too pregnant to work anymore. And they cannot be said to have any market power or economic independence when the costs of withholding their labor and selling it to a different employer are prohibitively high. People living paycheck to paycheck can’t just quit their shitty job any time they please in order to find a different but equally shitty job. The resultant loss of income can be ruinous.

We do not live in a free-market economy. Workers do not have equal standing with their employers. Enormous corporations dictate the shape of the economy and write their own laws giving them special privileges over everyone else. Stop using outdated free-market ideology to defend billionaires who constantly make sure that the market is anything but free so as to tip the scales entirely in their favor and to keep workers voiceless, powerless, unfree, dependent upon their insecure wages, and utterly shut out of any meaningful democratic process.

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Recently, Novartis and the University of Pennsylvania have chosen to cool down their relationship a bit so that they can start seeing other people. In 2019 they announced that the university would continue to work with Novartis to develop new CAR-T therapies, but with new limitations so that Penn could shop around for other pharmaceutical companies to partner with. “As Penn scientists continue to accelerate innovation in T-cell therapies, collaborations beyond one company are critical for us to advance these ideas and bring new options and hope to more patients,” Penn said in a press release.⁶⁴

I still love you honey, I just think that opening up our relationship will be good for both of us. And when the time is right, maybe we can come back to each other and stay exclusive for good. What do you think?

So this is how the healthcare industry thinks about competition. It’s not about wresting away drug patents from private ownership, it’s about creating even more options for private ownership! All hail the undemocratic free-market! Risky research and development costs are socialized by public funding, while sky-high profits continue to be privatized. What’s not to love?

The Novartis relationship with the University of Pennsylvania is hardly anything new or special. Just Novartis itself has around 300 other partnerships with academic institutions.⁶⁵ The company had a decade-long partnership with MIT starting in 2007, where Novartis put up $65 million to help fund the development of new drug manufacturing techniques.⁶⁶ According to MIT’s website:

Initial research is conducted primarily through PhD programs at MIT laboratories and involves MIT faculty members, students, postdoctoral fellows, and staff scientists. Novartis then applies the research to industrial-scale projects and pilots new manufacturing processes using its own pharmaceutical products.⁶⁷

Great. Here you go kids, here’s some money, now do the hard work of making some new do-dads and gizmos for us so that we can take them from you and use them in our own labs. Thanks!

What was the result of this much-touted private-public partnership? MIT developed technologies which allowed drugs to be created in small batches first before moving on to large-scale production. This allowed for greater experimentation and less waste in drug manufacturing.⁶⁸ And now Novartis gets to use those new technologies for its own products.

So that’s great that we’ve improved upon making new drugs. These new technologies may help reduce drug prices and get treatments to more people who need them. As one researcher told me, U.S. government funding is heavily weighted towards the development of new cures and treatments, but significantly less towards manufacturing technologies. “If I could change things,” he said, “I would have the U.S. government invest 100 times more funds into university research to invent advanced technologies that have the potential to massively drop the costs of manufacturing all of the new biotherapeutics being invented that are hard to manufacture reliably at low costs.”⁶⁹ Imagine that, a world where we wouldn’t have to rely on private companies funding university research departments just so that they can get their greedy, monopolistic hands on all the new technology our schools make.

Why are medical manufacturing technologies neglected? Why did it take a years-long partnership with a corporation to come up with the idea of making drugs in small batches first before scaling up? Any scenic painter worth their paint brushes will tell you that it is a good idea to mix your paints in very small dixie cups first in order to minimize waste, and then scale up later once you’re sure you’ve gotten the colors just right. Otherwise you’ll end up with gallons of the wrong colors destined for the slop bucket, not to mention an angry paint charge yelling at you to stop wasting money. Are we sure that these are the best medical science minds the world has to offer?

And did any of these new technologies, created by a public university, give Novartis an unfair advantage over other companies? Are the taxpayers who helped fund the university reaping the benefits from improved drug manufacturing techniques? Or is all that improved efficiency inordinately benefitting those in the upper echelons of Novartis? The $65 million that Novartis used to support this partnership with MIT needs to be weighed against the billions of dollars in profit that Novartis and other private companies stand to gain from these private-public partnerships where research and development is done by publicly funded organizations.

Corporations, as a rule, do not factor into their graphs and charts the costs that are borne exclusively by the public. Anyone who can’t afford life-saving treatments and therefore dies, or who goes into bankruptcy and loses their house in order to pay for expensive medications and surgeries, is not counted in the cost-benefit analyses of corporations. Those are public costs. Pharmaceutical companies do not bear those hardships and so they are considered successful and efficient innovators that the public rely upon and thank for gracing us with their monopolized drug treatments.

But if medications were treated as a public service instead of as market commodities, then those public costs – the bankruptcies, the lack of preventative care, the deaths – would actually be taken into account and the profit motive which is inherent to corporations would be disappeared. Novartis owns the patents to all kinds of drugs besides cell therapies such as Kymriah. If the company were a publicly controlled entity, then the price of its many drugs would fairly reflect their manufacture and administration costs, not the overinflated salaries of the company’s executives. Why do we let our healthcare outcomes be dictated by profit-seeking pigs? This current system ensures continued death and economic ruination for anyone living below the upper classes.

As Boldrin and Levin point out, an industry whose business model depends on patent protections, “must end up practicing rent-seeking and bribery, it must conceal or suppress relevant research findings, it must monitor doctors’ prescription behavior, it must employ a sales force three times the size of its research team, it must, finally, become one of the top donors of ‘political campaign contributions.’”⁷⁰ In this case, “political campaign contributions” is a euphemism for legalized bribery.

It is past time to put our healthcare system under democratic control, so that it may serve us, the people who pay for it anyway, not the vultures who profit from death and disease. Our country pays lip service to the ideal of democracy, but effectively curtails democratic impulses at every turn. If the Covid-19 pandemic is not enough to get those in power to let go of their stranglehold on life-saving medicines, then it is far past time to bring out the pitchforks.

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At breakfast, Ryan and Patrick asked me if there was anything else I wanted to do before I had to get back on the road up to Oregon. I asked them if there were any bookshops besides City Lights around and they said that Dog Eared Books was a good place to go. We drove over there and browsed the shelves for a half-hour or so. Patrick pointed out to me a book about the making of mead because I had been telling them over breakfast about how much I loved mead and about all the great meaderies up in Oregon that I was excited to sample while I was there. I found a couple short books, one by Susan Sontag called On the Pain of Others, and one by Howard Zinn called Disobedience and Democracy. I had never read anything by Sontag before, I only knew her by reputation from her essay On Photography, so I was excited to delve into her work. And I found Zinn’s arguments on civil disobedience to later be very helpful regarding our current climate of activism and protests.

I thanked Ryan and Patrick for being so generous as to host me at their place for the night and for showing me around some of San Francisco. They told me I was welcome any time.

I got in my car and I turned on the GPS to help get me out of the city. It told me I should be arriving in Ashland by around 9pm. It was a remarkably clear, sunny day in The Bay. I popped in my copy of Dessa’s Sound the Bells and headed north.

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Thank you for reading part 3 of this essay. You can find part 1 here and part 2 here. In the next installment, there will be an eccentric piano salesman, another Dessa show, and more analysis of our fucked up society. Stay tuned!

And if you haven’t heard the audio version of “American Terrorism,” give it a listen and share far and wide.

Find part 4 here and part 5 here.

1. Dessa, lyricist, "Warsaw," performed by Dessa, produced by Paper Tiger, on Parts of Speech, Doomtree Records, 2013, compact disc.

2. Rachel Brazil, "The Car T Cell Revolution: What Does It Offer, and Can We Afford It?," Cancerworld, last modified November 26, 2018, accessed February 28, 2021, https://archive.cancerworld.net/cutting-edge/the-car-t-cell-revolution-what-does-it-offer-and-can-we-afford-it/.

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